Assessment of Complementary Feeding of Canadian Infants

Intestinal Inflammation Clinical Trial

— Infant Feeding  

Official title:

Assessment of Complementary Feeding of Canadian Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790542
• Other study ID #: H2011:166
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: May 27, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial Summary

With the recent recommendation from Health Canada to extend exclusive breast-feeding to 6 months of age there has arisen concern about what is the best solid food to introduce at that time. Traditionally solids were introduced in Canada at 4-6 months and usually iron-fortified rice cereal was the first food of choice. New recommendations from Health Canada include meat as a potential first food as well as other iron fortified foods. This has lead to uncertainty of both public health officials and parents about the optimal introduction and choice of solids after exclusive breastfeeding.

In addition to meeting iron needs with the first solid food choice, the investigators are concerned about the possible generation of reactive oxygen species (ROS) in the gut of the infant fed traditional iron fortified cereals. Infant cereals are fortified at 25-30 mg iron per 100 g dry-weight. Absorption of the non-heme electrolytic iron ranges from 5-10% so that most of the residual iron enters the colon. Normally excess iron is sequestered by a variety of mechanisms in the body, but there is no such system for the sequestering of iron in the gut lumen. The investigators have shown that providing iron supplements to adults where the majority of the iron is unabsorbed passes through the digestive tract can lead to the generation of ROS in the colon. These effects are seen in adults receiving 1 mg/kg/day supplemental iron. By 5-6 months of age infants consuming iron fortified cereals will receive the same dose and are likely producing ROS in their digestive tract. This may cause inflammation and make infants more susceptible to disease. The investigators think that meats and infant cereals with phenolic antioxidants available from fruits will likely reduce the generation of ROS in vivo. Therefore the investigators wish to determine if traditional and newly recommended first foods are safe from a free radical and inflammatory perspective.

HYPOTHESES:

1. Consumption of infant cereals with iron will increase ROS generation in the gut

2. Consumption of infant cereals with iron and fruit will decrease ROS in the gut

3. Consumption of meat will not generate ROS

4. Consumption of iron fortified cereals or meat will maintain iron status during infancy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Full term infant

• Birth weight more than 2500g

• Absence of any medical conditions

Exclusion Criteria:

• Consumption of more than 200ml formula

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Generation of Reactive Oxygen Species
• Inflammation
• Intestinal Inflammation

Intervention

Other:
• Iron fortified cereal
Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)
• Iron fortified cereal with fruit

• Meat

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in 8OH-deoxyguanosine	Oxidative stress marker in the urine	Before introduction of study food and 2-3 weeks after introduction of study food	No
Other	Change in F2 Isoprostane	Oxidative stress marker in the urine	Before introduction of study food and 2-3 weeks after introduction of study food	No
Primary	Change in production of ROS	Production of reactive oxygen species	Before introduction of study food and 2-3 weeks after introduction of study food	No
Secondary	Change in Microbiome	Microflora of term infants before and after the introduction of solids	Before introduction of study food and 2-3 weeks after introduction of study food	No
Secondary	Change in Fecal Calprotectin	Inflammatory marker	Before introduction of study food and 2-3 weeks after introduction of study food	No
Secondary	Fecal non heme iron production	Non heme iron founded in infant cereal is less absorbed, remains in the gut, and excreted in the feces.	Before introduction of study food and 2-3 weeks after introduction of study food	No
Secondary	Dietary iron intake from first complementary food		3 days dietary record	No
Secondary	Micro and Macro nutrient intake of breastfed infants from first complementary food		3 days dietary record	No

External Links

•   Study Information